DesfluraneNCT06026033
The Effect of Anthropometrics on Desflurane Rise Time
An observational study of Desflurane and Anesthesia, General, run by Recep Tayyip Erdogan University at 1 site in Turkey (Türkiye).
Trial summary
Desflurane is increasingly used in general anesthesia. Its pharmacokinetic properties are known and its distribution is easily modeled. Yet these models fail in practice. In order to increase accuracy, any model should include cardiac output, alveolar ventilation and alveolar dead space, all of which are either hard… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Desflurane, Anesthesia, General
- What is being tested?
- Desflurane induction
- How many people
- 361 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2022to 1 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult patients, who are scheduled for elective general anesthesia. Maintenance of anesthesia with desflurane should be included in the routine anesthesia plan.
Who may be able to join
- age > 18 years
- planned elective surgery
- planned inhalational anesthesia
- planned use of desflurane
Who cannot join
- emergency surgery
- use of other inhalational anesthetic agent (sevoflurane, isoflurane, nitrous oxide)
- disclosed or recognized pregnancy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Recep Tayyip Erdogan University Medical Faculty, Department of Anesthesiology and Reanimation
Rize, 53100
About this study
Official title: Does Desflurane Take Longer to Reach Target Endtidal Concentration in Patients With Higher Body Muscle Content: a Pragmatic Study
Desflurane is increasingly used in general anesthesia. Its pharmacokinetic properties are known and its distribution is easily modeled. Yet these models fail in practice. In order to increase accuracy, any model should include cardiac output, alveolar ventilation and alveolar dead space, all of which are either hard to measure or impractical, at least.
A previous study performed by the same investigator showed that time to target endtidal concentration of sevoflurane is prolonged with increased cardiac output, but only if the patient has increased muscle mass. Although desflurane has lower muscle and fat solubility, our observations suggest a similar prolongation in case of increased muscle mass.
The investigators aim to investigate if patient characteristics such as gender, age, height, weight, body type prolongs time to reach target endtidal desflurane concentration in low flow anesthesia.
Read the detailed description
Low flow anesthesia is a frequently used application in anesthesiology practice. With the widespread use of modern anesthesia devices, the implementation of this application has become easier and its complications have been greatly reduced. It is routinely applied in our clinic, accompanied by both the protocols in the literature and the protocols the investigators have created.
Desflurane is the most recently developed inhaler anesthetic agent, and it has advantages such as faster recovery from anesthesia and less metabolism compared to sevoflurane. Although the physicochemical properties of desflurane are known, computer models for its use with low-flow anesthesia are based on desflurane's physicochemical properties, and not on the pharmacokinetic properties of patients. The inhaled induction times obtained with these models do not agree with our observations in practice.
In a study conducted in 2021, it was shown that parameters such as cardiac output and alveolar ventilation can increase the accuracy of these models. Among these models, the most frequently used one in the literature is included in the Gas Man simulator, which is also used in anesthesia specialty training. It allows one to perform studies that compare simulation-based and in vivo values are carried out.
A similar study was conducted by us with sevoflurane in 2018; A significant difference was found in the rate of increase in alveolar sevoflurane concentration according to cardiac output and muscle mass. Based on this study, the investigators aimed to investigate the effect of the patient's muscle mass evaluated by pragmatic measures such as height, body weight and body type on the rate of increase in the alveolar concentration of desflurane.
For this purpose, the investigators aimed to investigate the relationship between the time to reach the targeted alveolar desflurane gas concentration and patient characteristics. The investigators believe that the results of the study will be useful in explaining the factors affecting the induction of general anesthesia with desflurane.
- Conditions
- Desflurane, Anesthesia, General
- Being tested
- Desflurane induction
- Keywords
- Anesthetics, Inhalation, Anesthesia, General, Desflurane
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Desflurane inductionDrug
Following tracheal intubation, the fresh gas flow will be set to 1 liters/minute, desflurane vaporizer will be set to maximum.
| Study group | Role | What they receive |
|---|---|---|
| Patients scheduled for general anesthesia | Patients scheduled for elective general anesthesia will be included, if accepts and signs the informed consent. The inhalational anesthetic should be desflurane. No other inhalational agent should be used during the induction of anesthesia. The inspiratory and expiratory concentration of any inhalational agent should be zero before the induction of anesthesia. Receives: Drug: Desflurane induction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of rise in expiratory desflurane concentration
Correlation between the time required for the endtidal expiratory desflurane concentration to reach 8% and patient characteristics
Measured: intraoperative
Rate of rise in inspiratory desflurane concentration
Correlation between the time required for the endtidal inspiratory desflurane concentration to reach 6% and patient characteristics
Measured: intraoperative
Secondary outcomes (2)
Correlation between occurrence of hypertension and patient characteristics
Correlation between occurrence of hypertension defined as any measurement of systolic arterial blood pressure > 160 mmHg and patient characteristics
Measured: intraoperative
Correlation between occurrence of tachycardia and patient characteristics
Correlation between occurrence of tachycardia defined as any measurement of heart rate > 100/minute and patient characteristics
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2023
- Study start1 Feb 2022
- Primary completion30 Aug 2023
- Study completion1 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for DesfluraneStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 361 participants (actual)
Sponsor and investigators
- Lead sponsor
- Recep Tayyip Erdogan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Başar Erdivanlı, Recep Tayyip Erdogan University
- Investigators
- Başar Erdivanlı, Assoc. Prof., Study director, Recep Tayyip Erdogan University Medical Faculty, Department of Anesthesiology and ReanimationAlihan Madran, M.D., Principal investigator, Recep Tayyip Erdogan University Medical Faculty, Department of Anesthesiology and Reanimation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06026033
- Sponsor's protocol ID
- 2022/11
- Status last verified
- Dec 2023
- First submitted
- 31 Mar 2023
- Last updated
- 22 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Weber J, Missbach C, Schmidt J, Wenzel C, Schumann S, Philip JH, Wirth S. Prediction of expiratory desflurane and sevoflurane concentrations in lung-healthy patients utilizing cardiac output and alveolar ventilation matched pharmacokinetic models: A comparative observational study. Medicine (Baltimore). 2021 Feb 12;100(6):e23570. doi: 10.1097/MD.0000000000023570.
PubMed 33578509Athiraman U, Ravishankar M, Jahagirdhar S. Performance of computer simulated inhalational anesthetic uptake model in comparison with real time isoflurane concentration. J Clin Monit Comput. 2016 Dec;30(6):791-796. doi: 10.1007/s10877-015-9776-6. Epub 2015 Sep 19.
PubMed 26386708Philip JH. Using screen-based simulation of inhaled anaesthetic delivery to improve patient care. Br J Anaesth. 2015 Dec;115 Suppl 2:ii89-94. doi: 10.1093/bja/aev370.
PubMed 26658205
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Desflurane Take Longer to Reach Target Endtidal Concentration in Patients With Higher Body Muscle Content: a Pragmatic Study
- ClinicalTrials.gov ID
- NCT06026033
- Acronym / sponsor ID
- 2022/11
- Conditions
- Desflurane, Anesthesia, General
- Keywords
- Anesthetics, Inhalation, Anesthesia, General, Desflurane
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 361 participants (actual)
- Lead sponsor
- Recep Tayyip Erdogan UniversityUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 30 Aug 2023 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 6 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Desflurane is increasingly used in general anesthesia. Its pharmacokinetic properties are known and its distribution is easily modeled. Yet these models fail in practice. In order to increase accuracy, any model should include cardiac output, alveolar ventilation and alveolar dead space, all of which are either hard to measure or impractical, at least.
A previous study performed by the same investigator showed that time to target endtidal concentration of sevoflurane is prolonged with increased cardiac output, but only if the patient has increased muscle mass. Although desflurane has lower muscle and fat solubility, our observations suggest a similar prolongation in case of increased muscle mass.
The investigators aim to investigate if patient characteristics such as gender, age, height, weight, body type prolongs time to reach target endtidal desflurane concentration in low flow anesthesia.
Detailed description
Low flow anesthesia is a frequently used application in anesthesiology practice. With the widespread use of modern anesthesia devices, the implementation of this application has become easier and its complications have been greatly reduced. It is routinely applied in our clinic, accompanied by both the protocols in the literature and the protocols the investigators have created.
Desflurane is the most recently developed inhaler anesthetic agent, and it has advantages such as faster recovery from anesthesia and less metabolism compared to sevoflurane. Although the physicochemical properties of desflurane are known, computer models for its use with low-flow anesthesia are based on desflurane's physicochemical properties, and not on the pharmacokinetic properties of patients. The inhaled induction times obtained with these models do not agree with our observations in practice.
In a study conducted in 2021, it was shown that parameters such as cardiac output and alveolar ventilation can increase the accuracy of these models. Among these models, the most frequently used one in the literature is included in the Gas Man simulator, which is also used in anesthesia specialty training. It allows one to perform studies that compare simulation-based and in vivo values are carried out.
A similar study was conducted by us with sevoflurane in 2018; A significant difference was found in the rate of increase in alveolar sevoflurane concentration according to cardiac output and muscle mass. Based on this study, the investigators aimed to investigate the effect of the patient's muscle mass evaluated by pragmatic measures such as height, body weight and body type on the rate of increase in the alveolar concentration of desflurane.
For this purpose, the investigators aimed to investigate the relationship between the time to reach the targeted alveolar desflurane gas concentration and patient characteristics. The investigators believe that the results of the study will be useful in explaining the factors affecting the induction of general anesthesia with desflurane.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients scheduled for general anesthesia | – | Drug: Desflurane inductionPatients scheduled for elective general anesthesia will be included, if accepts and signs the informed consent. The inhalational anesthetic should be desflurane. No other inhalational agent should be used during the induction of anesthesia. The inspiratory and expiratory concentration of any inhalational agent should be zero before the induction of anesthesia. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients, who are scheduled for elective general anesthesia. Maintenance of anesthesia with desflurane should be included in the routine anesthesia plan.
Key inclusion criteria (4 listed)
- age > 18 years
- planned elective surgery
- planned inhalational anesthesia
- planned use of desflurane
Key exclusion criteria (3 listed)
- emergency surgery
- use of other inhalational anesthetic agent (sevoflurane, isoflurane, nitrous oxide)
- disclosed or recognized pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Desflurane inductionFollowing tracheal intubation, the fresh gas flow will be set to 1 liters/minute, desflurane vaporizer will be set to maximum. | Drug | Patients scheduled for general anesthesia |
Primary outcome
Rate of rise in expiratory desflurane concentration
Time frame: intraoperative
Correlation between the time required for the endtidal expiratory desflurane concentration to reach 8% and patient characteristics
Rate of rise in inspiratory desflurane concentration
Time frame: intraoperative
Correlation between the time required for the endtidal inspiratory desflurane concentration to reach 6% and patient characteristics
2 secondary outcomes
Correlation between occurrence of hypertension and patient characteristics
Time frame: intraoperative
Correlation between occurrence of tachycardia and patient characteristics
Time frame: intraoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2023.
- Results publication: PubMed 33578509Weber J, Missbach C, Schmidt J, Wenzel C, Schumann S, Philip JH, Wirth S. Prediction of expiratory desflurane and sevoflurane concentrations in lung-healthy patients utilizing cardiac output and alveolar ventilation matched pharmacokinetic models: A comparative observational study. Medicine (Baltimore). 2021 Feb 12;100(6):e23570. doi: 10.1097/MD.0000000000023570.
- Results publication: PubMed 26386708Athiraman U, Ravishankar M, Jahagirdhar S. Performance of computer simulated inhalational anesthetic uptake model in comparison with real time isoflurane concentration. J Clin Monit Comput. 2016 Dec;30(6):791-796. doi: 10.1007/s10877-015-9776-6. Epub 2015 Sep 19.
- Results publication: PubMed 26658205Philip JH. Using screen-based simulation of inhaled anaesthetic delivery to improve patient care. Br J Anaesth. 2015 Dec;115 Suppl 2:ii89-94. doi: 10.1093/bja/aev370.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Başar Erdivanlı, Assoc. Prof. study director
Recep Tayyip Erdogan University Medical Faculty, Department of Anesthesiology and Reanimation
Alihan Madran, M.D. principal investigator
Recep Tayyip Erdogan University Medical Faculty, Department of Anesthesiology and Reanimation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Desflurane and Anesthesia, General, run by Recep Tayyip Erdogan University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of rise in expiratory desflurane concentration (time frame: intraoperative). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06026033, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2023.